Sterile sleeve/connector assembly

ABSTRACT

The sterile sleeve/connector assembly includes a joint formed between a sterile sleeve and a connector. The sleeve is made of a tube of thin flexible material, the connector includes a hub having an annular groove therein, and the joint includes an O-ring which is positioned within a bight of an inwardly inverted end portion of the sleeve and within the groove of the connector hub. The apparatus used in forming the assembly comprises a barrel member having a lumen, a distal end and a proximal end. The barrel member has a diameter approximately equal to a diameter of the hub the connector and less than the diameter of the sleeve. The method for using the apparatus comprises the steps of (a) pushing the O-ring onto an outer surface of the barrel member at the distal end of the barrel member; (b) sliding a sleeve over the barrel member; (c) inverting an end portion of the sleeve into the distal end of the lumen of the barrel member; (d) sliding the hub of the connector into the inverted end portion of the sleeve at the distal end of the lumen; (e) forcing the O-ring off the distal end of the barrel member, into a bight of the inverted end portion of the sleeve and into the annular groove in the hub of the connector; and (f) removing the connector from within the barrel member and pulling on the connector until the entire sleeve is removed from over the barrel member.

This is a continuation of application Ser. No. 295,680, filed Jan. 11,1989, now abandoned, which is a division of Ser. No. 163,746, filed Mar.3, 1988, now U.S. Pat. No. 4,821,398.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a method and apparatus for attaching asterile sleeve to a connector, such as a distal fitting for the sterilesleeve, and the assembly formed thereby. More specifically, the methodand apparatus enable a sterile sleeve to be attached to a connector insuch a manner that a loose end of the sleeve is tucked within the bodyof the sleeve and over a portion of the body of the connector, as willbe described in greater detail hereinafter.

2. Description of the Prior Art

Heretofore various methods and apparatus have been proposed for forminga joint or sealed coupling between a sterile sleeve and a connectortherefor. All such methods and apparatus form the joint or coupling byplacing an end section of a sterile sleeve over a connector body andthen feeding an O-ring over the end of the, sterile sleeve and/or theconnector body for securing the sterile sleeve to the connector bodywhen the O-ring placed over the sleeve and connector is received withinan annular groove provided on the connector body.

An example of such sterile sleeve/connector assembly is disclosed in theHampson U.S. Pat. No. 4,327,735 the disclosure of which is incorporatedherein by reference. As disclosed in this patent, a sleeve/introducerassembly is fitted over a medical catheter for the purpose of protectingthe catheter within the sleeve from contaminants thereby to maintain thecatheter in a sterile condition.

Applicant's assignee, Cordis Corporation of Miami Lakes, Florida, sellssuch sleeve/introducer assemblies under the name or mark "Steri-Sleeve"which is a contraction of the term "Sterile Sleeve" used herein.

Such a "Steri-Sleeve" is disclosed on page 102 of the January 1988Cordis Corporation Catalog, the disclosure of which is incorporatedherein by reference.

Such joints or couplings formed by prior art methods and apparatus haveleft a straggling, loose end of the sterile sleeve extending from theO-ring over the connector body to which the sterile sleeve is joinedSuch a straggling loose end makes separation of the joint simple All auser need do is gently pull on the sleeve, against. the O-ring, andremove the sleeve from entrapment beneath the O-ring to cause aseparation of the sleeve from the connector.

By utilization of the apparatus and method of the present invention informing the joint in a sterile sleeve/connector assembly of the presentinvention, the O-ring is received within or encased within an inwardlyturned or inverted looped end portion of the sterile sleeve, with thepreviously straggling, loose end portion of the sterile sleeve nowextending inwardly into the lumen of the sterile sleeve with the O-ringpositioned to entrap the inwardly extending end portion of the sleevewithin an O-ring receiving annular groove provided on a connector, withthe remainder of the sterile sleeve looping outwardly and back over theentrapped end portion of the sterile sleeve and extending over theconnector. Such joint or coupling formed by the method and apparatus ofthe present invention provides a joint which is much more difficult toseparate and provides a neat termination of the sleeve about the O-ringand over the connector in the manner described so that there is no loosestraggling end, making the external surface of the joint more regular.

As will be described in greater detail hereinafter, it is believed thatthe joint in a sterile sleeve/connector assembly of the presentinvention can only be accomplished by use of the particular method andapparatus disclosed herein.

SUMMARY OF THE INVENTION

According to the present invention there is provided a sterilesleeve/connector assembly adapted to be mounted on a medical catheterand comprising a tubular connector including a hub, a sterile sleeve forprotecting the catheter received therein from contaminants thereby tomaintain the catheter in a sterile condition and a joint formed betweenan end portion of said sterile sleeve and said hub of said connector,said sterile sleeve being made of a tube of thin flexible material, saidhub having an external annular groove therein, and said joint includingan elastic O-ring which is positioned within a bight formed betweeninner and outer sleeve rings of an inwardly inverted end portion of saidsleeve, against the inner sleeve ring of said sleeve, and within andagainst the bottom of said groove in said hub.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prior art joint or coupling between asterile sleeve and a connector in a sterile sleeve/connector assemblyformed by known methods.

FIG. 2 is a perspective view of the joint or coupling of the presentinvention between a sterile sleeve and a connector in a sterilesleeve/connector assembly formed by the method and apparatus of thepresent invention.

FIG. 3 is a longitudinal sectional view through the joint or coupling inthe sterile sleeve/connector assembly of the present invention formed bythe method and apparatus of the present invention and is taken alongline 3--3 of FIG. 2.

FIG. 4 is a side plan view of one embodiment of an apparatus forcarrying out the method for forming the joint or coupling of the presentinvention, and shows the apparatus in an at-rest position.

FIG. 5 is a side plan view of the apparatus shown in FIG. 4 but shownhere in an actuated position.

FIG. 6 is a perspective view of a bullet-shaped plug and a flexibleelastomeric O-ring which can be used with the apparatus shown in FIGS. 4and 5 for forming the joint or coupling of the present invention.

FIG. 7 is a side plan view of the plug shown in FIG. 6 with an O-ringpositioned thereon, and shows a distal end of the plug inserted into adistal end of an inner barrel member of the apparatus shown in FIGS. 4and 5.

FIG. 8 is a side plan view of the bullet-shaped plug similar to the viewshown in FIG. 2 and shows the plug moved axially away from the innerbarrel member after the O-ring has been moved to a position on a distalend portion of the inner barrel member of the apparatus shown in FIGS. 4and 5.

FIG. 9 is a side plan view of the distal end portion of the inner barrelmember shown in FIGS. 7 and 8 and shows a sterile sleeve positioned overthe distal end portion of the inner barrel member of the apparatus shownin FIGS. 4 and 5.

FIG. 10 is a side plan view of the distal end portion of the innerbarrel member of the apparatus shown in FIGS. 4 and 5 and of a connectorused in forming the sterile sleeve/connector assembly of the presentinvention positioned for insertion into the distal end portion of thinner barrel member after the sterile sleeve has been slid over theinner and outer barrel members of the apparatus shown in FIGS. 4 and 5and an end portion of the sleeve has been inwardly inverted into thedistal end portion of the inner barrel member.

FIG. 11 is a side plan view of the connector positioned within thedistal end portion of the inner barrel member of the apparatus shown inFIG. 10 and the sleeve end portion shown in FIG. 10.

FIG. 12 is a longitudinal sectional view through the distal end portionof the inner and outer barrel members shown in FIG. 11, shows a depthregulator fixed within a distal end of a lumen of the inner barrelmember and shows a connector within the lumen of the inner barrel memberand abutting the depth regulator.

FIG. 13 is a longitudinal sectional view through the distal end portionof the barrel members similar to the view shown in FIG. 12 but after thedistal end portion of the outer barrel member has been positioned overthe distal end portion of the inner barrel member to move the O-ringinto a bight of the inwardly inverted end portion of the sleeve and intoa groove of the connector hub.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings in greater detail, there is illustrated inFIG. 1 a perspective view of a prior art joint or coupling formedbetween a sterile sleeve and a connector, such as a distal fitting forthe sterile sleeve, by the use of an O-ring.

As illustrated, the joint or coupling formed by known methods andapparatus is formed in a manner wherein an end portion of a sterilesleeve is fitted over a hub of a connector body, and then an O-ring,which has a diameter less than the diameter of the hub of the connectorbody, is slid over the sleeve and connector body to position where theO-ring is received within an annular groove provided in the outersurface of the hub of the connector body for receiving the O-ringtherein for securing the sterile sleeve to the connector.

Such a prior art sleeve and connector body is disclosed in the HampsonU.S. Pat. No. 4,327,735 and on page 102 of the Cordis CorporationJanuary 1988 catalog. A catheter (not shown) is received in the sleeveand maintained in a sterile condition by the sleeve.

As shown, in the prior art joint or coupling, an end portion of thesterile sleeve extends distally of the O-ring over the connector body,leaving a loose, straggling, irregular end portion of the sterile sleeveexposed. The leaving of such an exposed, irregular loose end portionallows the joint or coupling to be easily disrupted, such as by pullingon the elongate body portion of the sterile sleeve to cause the O-ringto roll within the groove until the end of the sterile sleeve escapesentrapment from under the O-ring. Such irregular loose end portion isavoided in the joint or coupling in a sterile sleeve/connector assemblyconstructed with the method and apparatus of the present invention aswill be described in greater detail hereinafter.

In FIG. 2, a joint or coupling 10 in a sterile sleeve/connector assembly11 constructed according to the teachings of the present invention isformed between a connector 12 and a sterile sleeve 14 in such a mannerthat the joint 10 has a smooth external surface and no straggling,irregular loose end portion of the sleeve 14 exposed.

In FIG. 3, there is shown a longitudinal sectional view through thejoint or coupling 10 in a sterile sleeve/connector assembly 11constructed according to the method of and with the apparatus of thepresent invention.

The joint 10 includes an O-ring 16 within a bight portion 17 of aninwardly inverted, U-in-cross-section end portion 18 of the sleeve 14,the O-ring 16 and the bight portion 17 being received in an annulargroove 19 formed in a hub 20 of the connector 12. In this way, the endportion 18 of the sleeve 14 is coupled or secured to the connector 12 bythe tight fit of the O-ring 16 in the groove 19.

With the joint 10 formed in this manner, a greater amount of tension orpulling force must be applied to the sleeve 14 to disengage the sleeve14 from the connector 12.

In FIG. 4, there is shown one embodiment of an apparatus 30 forpracticing the method of the present invention to construct the joint orcoupling 10 of the present invention. The apparatus 30 is shown in FIG.4 in an at-rest position and has a pistol-like shape including a barrelportion 32, a handle portion 33 and a trigger 34.

The barrel portion 32 of the apparatus 30 includes an inner barrelmember 35 and an outer barrel member 36, with the inner barrel member 35being attached to the handle portion 33 in a fixed position by a bracket37. The outer barrel member 36 is slidably received on and over theinner barrel member 35 and is spring biased against the .handle portion33 by a biasing assembly 39. The biasing assembly 39 includes a rod 40which extends through the handle portion 33, a spring 41 received arounda proximal end portion 42 of the rod 40 and a bracket 43 connected tothe outer barrel member 36 and a distal end 44 of the rod 40.

The spring 41 is slightly compressed between a rear wall 45 of thehandle portion 33 and a stop 46, in the form of a washer 46 fixed on therod 40 by a nut 48 which may be threadedly received on asmaller-in-diameter threaded proximal end 50 of the rod 40. The distalend 44 of the rod 40 is fixed to a lower end 54 of the bracket 43. Anupper end 58 of the bracket 43 has a bore (not shown) in which the outerbarrel member 36 is fixed. The trigger 34 is pivotably connected to thehandle portion 33 for pivotal movement about a pivot axis 59. An upperend of the trigger 34 is also pivotably connected to the rod 40, asshown in phantom, such that squeezing of the trigger 34 causes movementof the rod 40, as shown by arrow A in FIG. 5, from a proximal positionto a distal position against, and compressing, the spring 41 to move theouter barrel member 36 forwardly over the inner barrel member 35 apredetermined distance as determined by engagement of a pin or detent 60extending laterally outwardly from the trigger 34 with a notch 61 in thehandle portion 33. This predetermined distance of relative movementbetween the barrel members 35 and 36 is such that a distal end 62 of theouter barrel member 36 is moved to a position covering or extendingslightly outwardly of a distal end 63 of the inner barrel member 35(FIG. 5).

FIG. 5 shows the relative movement between the outer barrel member 36and the inner barrel member 35 when the trigger 34 is squeezed In thisposition, the outer barrel member 36 is shown with its distal end 62extending slightly past the distal end 63 of the inner barrel member 35.

Upon release of the trigger 34, the rod 40 is biased by the spring 41 tothe state shown in FIG. 4.

The use of the apparatus 30 will be described in greater detail inconnection with the description of FIGS. 8-13, which illustrate thesteps of the method of the present invention, utilizing the apparatus 30of the present invention, to form the joint 10 of the present inventionbetween the sterile sleeve 14 and the connector 12 therefor.

Also it is to be understood that a more sophisticated pneumatic,electric or hydraulic apparatus can be used for causing relativemovement between the barrel members 35 and 36. It is contemplated thatthe best mode for carrying out the teachings of the present inventionwill include a power operated apparatus for moving one barrel memberrelative to the other after the sleeve is properly positioned over thebarrel members 35 and 36 and suction is first applied the inner barrelmember 35 to pull the end portion 18 of the sleeve 14 into the lumen 78of the inner barrel member 35.

Further, although it is preferable to use two barrel members, the joint10 can be formed using only the single barrel member 35, with theapplication of finger pressure replacing the pushing of the O-ring 16off the inner barrel member 35 by the outer barrel member 36.

Turning now to FIG. 6, there is illustrated therein a bullet-shaped plug70. The plug 70 has a conical or elliptical distal end portion 72, abody portion 74, and a proximal flange portion 76 The plug 70 may alsohave a longitudinal bore 77 therein which is sized to receive a pintherein.

There is also illustrated in FIG. 6, the O-ring 16 in a position to befed over the elliptical distal end portion 72 of plug 70 and expandedthereon to a stretched position (shown in phantom) along the bodyportion 74 of the plug 70.

Once the O-ring 16 is positioned at a somewhat distal location along thelength of the body portion 74 of the plug 70, the distal end portion 72of the plug member 70 is inserted within a lumen 78 (FIGS. 12 and 13) ofthe inner barrel member 35 of the apparatus 30, as shown in FIG. 7. Theouter diameter of the body portion 74 of the plug member 70 isapproximately equal to the outer diameter of the inner barrel member 35and the O-ring 16 can be rolled off of the plug 70 and onto an outersurface 80 of the inner barrel member 35 at the distal end 63 thereof.

Once the plug 70 is inserted within the lumen 78 of the inner barrelmember 35, the O-ring 16 is then pushed, such as by the thumb of theuser, in a direction shown by the arrow B, over and onto the outersurface 80 of the inner barrel member 35. The plug 70 is removed fromits position within the lumen 78 of the inner barrel member 35 as shownin FIG. 8 and set aside.

It is to be understood that the plug 70 is an optional part of theapparatus 30 and can be eliminated. Other more sophisticated means canbe used for placing the O-ring 16 on the distal end 63 of the innerbarrel member 35 and such placement could even be accomplished manuallywithout the aid of the plug 70.

Next, as illustrated in FIG. 9, an end 82 of the sterile sleeve 14,which is opposite to the end section 18 to be used in formation of thejoint 10, having a diameter which is greater than the outer diameter ofthe outer barrel member 36, is fed over and along the length of thebarrel portion 32, until it reaches the bracket 43 which acts as a stop43 (FIGS. 4 & 5). The remainder of the sleeve 14 continues to be fedover the barrel portion 32 until only the small end section 18 of thesleeve 14, having a predetermined length, remains extending outwardly ofthe distal end 63 of the inner barrel member 35. This end section 18 ofthe sleeve 14 eventually forms an inwardly inverted end section 84 ofthe sleeve 14, as illustrated in FIGS. 10-13.

Turning now to FIG. 10, once the greater length of the sleeve 14 hasbeen fed over the barrel portion 32 of the apparatus 30, a predeterminedlength of the outwardly extending end section 18 of the sleeve 14 isinverted into the lumen 78 of the inner barrel member 35, as will bedescribed in greater detail in connection with the description of FIGS.12 and 13. The smaller-in-diameter hub 20 of the connector 12, havingthe groove 19 therein is then pushed into the lumen 78 of the innerbarrel member 35 a predetermined distance, as will be describedhereinafter, and frictionally retains the inverted portion 84 of thesleeve 14 within the lumen 78.

In FIG. 12, there is shown a longitudinal sectional view through thedistal end of the barrel portion 32.

In order to assure that the end portion 18 of the sleeve 14 is onlyinverted to a predetermined depth, a depth regulator 86 is provided forpositioning within the lumen 78 of the inner barrel member 35. In thisrespect, if too much of the end portion 18 is inverted, the invertedsection 84 may cover or overhang a throughbore (not shown) within theconnector 12 and interfere with the flow of materials therethrough.Also, if too little of the end portion 18 of the sleeve 14 is inverted,not enough of the inverted end portion 84 may extend over the connector12 to form a secure joint 10. Also, to assist in making a determinationof the appropriate length of the end 18 to extend outwardly from thedistal end 63 of the inner barrel member 35, so that, upon inversion ofthe end portion 18, the end of the inverted portion 84 rests against thedepth regulator 86, the depth regulator 86 is provided with a centrallocating pin 88 which extends distally outwardly from the distal end 63of the inner barrel member 35, when the depth regulator 86 isappropriately positioned within the inner barrel member 35. The positionof a tip 89 of the locating pin 88 serves as a guide as to the length ofthe section 18. In this respect, a user aligns the end of the section 18with the tip 89 of the pin 88 to assure that the end of the invertedportion 84 will rest against the depth regulator 86 when the section 18is inverted into the lumen 78 of the inner barrel member 35.

Preferably, the disc shaped depth regulator 86 is press fitted into thelumen 78 of the inner barrel member 35 and is fixed in place. For thisreason, the plug 70 has the bore 77 for receiving the pin 88.

The inversion of the section 18 may be accomplished by manual methods orby other methods. For example, a vacuum may be applied to a proximal end90 (FIGS. 4 and 5) of the inner barrel member 35 to pull the section 18of the sleeve 14 into the lumen 78 of the inner barrel member 35 to formthe inverted portion 84 of the sleeve 14. To allow for the vacuum effectto extend through the thickness of the depth regulator 86, the depthregulator 86 is provided with several longitudinal throughbores 92 whichare radially disposed about the locating pin 88.

The depth regulator 86 also has a further function with regard toappropriate placement of the hub 20 of the connector 12 within the innerbarrel member 35. As shown, once the depth regulator 86 has beenappropriately positioned within the lumen 78 of the inner barrel member35, the hub 20 of the connector 12, having a central throughboretherein, is fed over the locating pin 88 with the locating pin 88extending into the throughbore of the connector 12 and is pushed intothe lumen 78 of the inner barrel member 35 until it abuts against thedepth regulator 86. At this abutting position, the groove 19 of the hub20 is just distal to the distal end 63 of the inner barrel member 35,with the inverted portion 84 of the sleeve 14 being frictionallyretained between the hub 20 of the connector 12 and the inner barrelmember 35.

The O-ring 16, engaging the outer surface 80 of the inner barrel member35, now has the inverted portion 84 of the sleeve 14 extendingtherebeneath with the remainder of the sleeve 14 extending proximallythereover. The distal end 62 of the outer barrel member 36 is shownpositioned against the O-ring 16, acting as a stop member for the O-ring16 on the outer surface 80 of the inner barrel member 35.

Then, as illustrated in FIG. 13, and with reference to the position andactuation of the trigger 34 of the apparatus 30 as illustrated in FIG.5, when the trigger 34 of the apparatus 30 is actuated, it causes theouter barrel member 36 to move over the inner barrel member 35 to movethe O-ring off the distal end 63 of the inner barrel member 35 into thebight 17 of the inverted portion 84 of the sleeve 14 and into the groove19 of the hub 20. Here, the distal ends 63 and 62 of the inner and outerbarrel members 35 and 36, respectively, are shown, with the distal end62 of the outer barrel member 36, upon actuation of the trigger 34,being pushed distally over and into alignment with the distal end 63 ofthe inner barrel member 35 to force the O-ring 16 off the outer surface80 of inner barrel member 35 and into the groove 19 of the connector 12.

Once the formation of the joint 10 has proceeded to this stage, thetrigger 34 is released, causing the outer barrel member 36 to retract ormove proximally over the inner barrel member 35 and the apparatus 30 iswithdrawn from its position within the sleeve 14.

Upon the formation of the joint 10 as described above, variousadvantages will be observed, the first one being the provision of asmoothened outer surface to the joint 10. Secondly, as described above,a greater pulling action or force will be required to dislodge theO-ring 16 from engagement within the annular groove 19 due to the factthat the O-ring 16 is encased within the bight 17 of the inwardlyinverted portion 84 of the sterile sleeve 14.

Also, modifications can be made to the apparatus of the presentinvention without departing from the teachings thereof.

Accordingly, the scope of the invention is only to be limited asnecessitated by the accompanying claims.

I claim:
 1. A sterile sleeve/connector assembly for mounting on amedical catheter and comprising: (a) a tubular connector including ahub, (b) a sterile sleeve for protecting the catheter received thereinfrom contaminants thereby to maintain the catheter in a sterilecondition, and (c) a joint formed between an end portion of said sterilesleeve and said hub of said connector, said hub comprising a cylindricalend portion having an external annular groove therein, said sterilesleeve being made of a tube of thin flexible material and having an endportion which is received on said hub end portion and which is foldedinwardly within the sleeve so as to form an inner sleeve ring within anouter sleeve ring which are connected by a generally toroidallyextending bight portion and said joint including an elastic O-ring whichis positioned within said bight portion received within said groove andconnecting said inner and outer sleeve rings of said inwardly invertedend portion of said sleeve, said O-ring bearing against the bightportion and the inner sleeve ring of said sleeve and within and againstthe bottom of said groove in said cylindrical end portion of said hub.2. A sterile sleeve/connector assembly for mounting on a medicalcatheter and comprising a sterile sleeve for protecting the catheterreceived therein from contaminants thereby to maintain the catheter in asterile condition, a connector including a hub, and a joint formedbetween said hub of said connector and said sterile sleeve, said hubincluding a cylindrical end portion having an external annular groovetherein, said sterile sleeve being made of a tube of thin flexiblematerial and having an end portion which is received on said hub endportion and which is folded inwardly within the sleeve so as to form aninner sleeve ring within an outer sleeve ring which are connected bygenerally toroidally extending bight portion, and said joint comprisingsaid annular groove, said end portion of said sterile sleeve and anelastic O-ring received over said inner sleeve ring and said bightportion of said sterile sleeve and in said groove, said joint beingassembled using a single barrel member by pushing said O-ring onto anouter surface of the distal end of the barrel member; sliding saidsterile sleeve over the barrel member; inverting one end portion of saidsleeve into the lumen of the barrel member at the distal end of thebarrel member to form said inner and outer sleeve rings; sliding saidcylindrical portion of said hub of said connector into the inverted endportion of said sleeve within the lumen at the distal end of the barrelmember; forcing said O-ring of the distal end of the barrel member, intosaid bight portion between said inner and outer sleeve rings of theinverted end portion of said sleeve and into said annular groove in saidhub of said connector; and, removing said connector from within thebarrel member and pulling of said connector until the entire sleeve isremoved from over the barrel member.